EU Archives -

Sanofi has claimed approval in the EU for Xenpozyme as a treatment for acid sphingomyelinase deficiency (ASMD) –

Celebrations for ASMD community as EU clears Sanofi’s Xenpozyme

https://pharmaphorum.com/news/celebrations-for-asmd-community-as-eu-clears-sanofis-xenpozyme/

BioMarin gene therapy for haemophilia on course for EU approval

Phil Taylor BioMarin, EU, gene therapy, haemophilia A, regulatory approval, Roctavian 0 Comment

The EMA’s human medicines advisory committee has recommended that BioMarin Pharmaceutical’s haemophilia A gene therapy Roctavian be approved

BioMarin gene therapy for haemophilia on course for EU approval

https://pharmaphorum.com/news/biomarin-gene-therapy-for-haemophilia-on-course-for-eu-approval/

News/ News/ Oncology

J&J, Legend get EU nod for myeloma CAR-T Carvykti

Phil Taylor CAR-T therapies, Carvykti, EU, immuno-oncology, Johnson & Johnson, multiple myeloma, Oncology, regulatory approval 0 Comment

Johnson & Johnson and Legend Biotech will arrive at next week’s ASCO congress with a new EU approval

J&J, Legend get EU nod for myeloma CAR-T Carvykti

https://pharmaphorum.com/news/jj-legend-get-eu-nod-for-myeloma-car-t-carvykti/

Market Access/ News/ News

PTC gets green light for gene therapy Upstaza in EU

Phil Taylor AADC deficiency, CHMP, EU, gene therapy, PTC Therapeutics, rare disease, Upstaza 0 Comment

PTC Therapeutic’s Upstaza gene therapy for patients with genetic disorder AADC deficiency has been recommended for approval in

PTC gets green light for gene therapy Upstaza in EU

https://pharmaphorum.com/news/ptc-gets-green-light-for-gene-therapy-upstaza-in-eu/

News/ News/ R&D

EU imposes Horizon funding block on UK scientists

Phil Taylor Brexit, EU, Horizon Europe programme, R&D, trade, UK 0 Comment

UK scientists are being denied from joining the €95 billion Horizon research funding programme as a dispute over

EU imposes Horizon funding block on UK scientists

https://pharmaphorum.com/news/eu-imposes-horizon-funding-block-on-uk-scientists/

Market Access/ News/ News/ News/ Sales and Marketing

Idorsia is first to EU market with orexin insomnia drug

Phil Taylor Belsomra, Dayvigo, Eisai, EU, Idorsia, insomnia, Quviviq, regulatory approval 0 Comment

Idorsia has become the first drugmaker in the EU to claim approval for a drug for chronic insomnia

Idorsia is first to EU market with orexin insomnia drug

https://pharmaphorum.com/news/idorsia-is-first-to-eu-market-with-orexin-insomnia-drug/

Market Access/ News/ News

Biogen pulls EU application for Alzheimer’s drug Aduhelm

Phil Taylor Aduhelm, Alzheimer's disease, Biogen, CHMP, ema, EU, market access, neurology 0 Comment

Biogen has given up on seeking approval for its Alzheimer’s disease therapy Aduhelm in the EU, saying that

Biogen pulls EU application for Alzheimer’s drug Aduhelm

https://pharmaphorum.com/news/biogen-pulls-eu-application-for-alzheimers-drug-aduhelm/

News

Drugmakers pledge shorter launch times for drugs in EU

Phil Taylor access, EFPIA, EU, inequality, Value-based pricing 0 Comment

Pharmaceutical companies have said they will try to carve months off the time between approval and launch for

Drugmakers pledge shorter launch times for drugs in EU

https://pharmaphorum.com/news/drugmakers-pledge-shorter-launch-times-for-drugs-in-eu/

News

Immunocore gets EU nod for TCR cancer therapy Kimmtrak

Phil Taylor EU, immuno-oncology, Immunocore, Kimmtrak, Oncology, regulatory approval, TCR, uveal melanoma 0 Comment

Immunocore now has approval on both side of the Atlantic for Kimmtrak – the first cancer therapeutic based

Immunocore gets EU nod for TCR cancer therapy Kimmtrak

https://pharmaphorum.com/news/immunocore-gets-eu-nod-for-tcr-cancer-therapy-kimmtrak/

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